MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT 0° X3 INSERT 36MM ID; IMPLANT

Catalog Number 623-00-36E

Device Problems Mechanical Problem (1384); Use of Device Problem (1670); Device Operates Differently Than Expected (2913); Misassembly by Users (3133)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/21/2015

Event Type  malfunction  

Event Description

It was reported that the liner would not impact.Surgeon tried four times, second liner impacted first try.

Manufacturer Narrative

An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Additional information was requested and if it becomes available will be submitted in a supplemental report.Not returned to manufacturer.

Manufacturer Narrative

Review of device history records indicates the lot was manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.The subject liner was returned in used condition with damages consistent with the reported implantation attempt.Minor gouging damage on the locking feature indicates debris was present between the mating faces of the liner and shell during insertion and attempted locking.The event was confirmed.The investigation determined the likely root cause of the event to be debris trapped between the mating faces of the liner and shell during insertion and attempted locking.There is no indication at this time that the design, materials, or manufacturing of the subject device contributed to the event.If additional information becomes available, this investigation will be reopened.

Event Description

It was reported that the liner would not impact.Surgeon tried four times, second liner impacted first try.

• Brand Name: TRIDENT 0° X3 INSERT 36MM ID
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: keyla navedo ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4777589
• MDR Text Key: 21066723
• Report Number: 0002249697-2015-01593
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K033716
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,health professional,oth
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2020
• Device Catalogue Number: 623-00-36E
• Device Lot Number: EA1PET
• Other Device ID Number: STERILE LOT# MSGPE12K4
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/12/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/16/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other